Azithromycin Impurity P CAS CATO-C4X-100352

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100352
Molecular FormulaC39H72N2O13
Molecular Weight776.99 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azithromycin Impurity P CAS CATO-C4X-100352 chemical structure

Description

CATO manufactures Azithromycin Impurity P under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Azithromycin Impurity P (CAS CATO-C4X-100352) is a certified pharmaceutical impurity reference standard with the molecular formula C39H72N2O13 and a molecular weight of 776.99 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Azithromycin Impurity P is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 776.99 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular FormulaC39H72N2O13
Molecular Weight776.99 g/mol
Purity>90%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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